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PHL

PHL
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PHL

Product catalog summary
Overview: This document provides comprehensive details on the PHL Proximal Humeral Locking Plate, a medical device for stabilizing humeral head fractures. It covers specifications, surgical procedures, material properties, and guidelines for use and sterilization.
Specifications: The locking plate features multidirectional locking with customizable screw angles, using Ø 3.5 mm cortical screws and Ø 4.2 mm locking cancellous screws. It is anatomically contoured, available in 3 or 4-hole configurations, and made from titanium for enhanced fatigue strength and reduced inflammation risk.
Indications and Contraindications: Suitable for dislocated, unstable 2, 3, and 4-segment fractures, valgus-impacted 4-segment fractures, and pseudoarthroses. Not recommended for diaphyseal fractures of the humeral head.
Surgical Technique: Involves deltopectoral access, fragment repositioning, and fixation with screws. The plate is positioned 5 mm distal to the proximal end of the tuberculum majus and 10 mm dorsal to the posterior edge of the sulcus intertubercularis.
Postoperative Care: Encourages early functional movement. In cases of poor bone quality, a shoulder bandage may be used for up to 4 weeks, with guided exercises.
Material and Design: Constructed from titanium and TiAL6V4 ELI, the design minimizes cold bonding risk and facilitates removal post-healing.
Locking Mechanism: Utilizes a screw material slightly harder than the plate, allowing the screw head to form a thread into the plate without cutting, enabling screw resetting up to three times.
Sterilization and Maintenance: Provides detailed cleaning, disinfection, and sterilization guidelines, recommending steam sterilization and specific handling instructions.
Warnings and Precautions: Stresses adherence to instructions, avoiding implant design alterations, and ensuring device compatibility. Regular postoperative follow-ups are advised.
Conclusion: The PHL Proximal Humeral Locking Plate offers stable fixation for humeral head fractures, especially in osteoporotic bones, with proper surgical technique and postoperative care being crucial.
Post-Implantation Instructions: Patients should report any negative changes or accidents post-implantation.
Hospital Responsibility for Instruments: Instruments require proper care and disposal if worn out. Returned products must be cleaned, disinfected, inspected, and sterilized.
Important Note: Instructions are validated for reusable medical products. Reconditioners must ensure effective reconditioning, with deviations evaluated for efficiency and potential consequences.
Symbols and Standards: Lists symbols and standards like RL 93/42/EWG, ÖNORM EN ISO 13485, and ISO 17664 related to sterilization and product specifications.
Contact Information: I.T.S. GmbH, part of the MED-HOLD GROUP, located at Autal 28, 8301 Lassnitzhöhe, Austria, with contact details provided.
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Catalog excerpts

PHL-1

PROXIMAL HUMERAL LOCKING PLATE small emergency team for broken bones®

 Open the catalog to page 1
PHL-2

optional locking - non locking in shaft optimal reconstruction of the joint easy adjustment due to longhole HUMERAL HEAD PLATE emergency team for broken bones® 37351-XX-N Cortical Screw, locking, D=3.5mm, SH 61273-100 Spiral Drill, D=2.7mm, L=100mm, AO Connector 56252 Screwdriver, WS 2.5, self-holding sleeve 32351-XX Cortical Screw, D=3.5mm 61273-100 Spiral Drill, D=2.7mm, L=100mm, AO Connector 56252 Screwdriver, WS 2.5, self-holding sleeve 37422-XX-N Cancellous Screw, locking, D=4.2mm, SH 61253-180 Spiral Drill, D=2.5mm, L=180mm, AO Connector 56252 Screwdriver, WS 2.5, self-holding sleeve 35204-228...

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PHL-3

Features Features Implant: Material: • ultidirectional Locking M • ree choice of screw angle F • 3.5 mm Cortical Screw Ø • 4.2 mm locking Cancellous Ø Screw • natomically contoured A • , 4 - hole 3 • late material: Titanium P • aterial of screws: TiAL6V4 ELI M • asier removal of implant after fracture has E healed • mproved fatigue strength of implant I • educed risk of cold bonding R • educed risk of inflammation and allergy R locking HUMERAL HEAD PLATE All I.T.S. locking plates are anatomically pre-contoured. In the unlikely event that the plate has to be formed to the bone please notice that...

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PHL-4

Indications Contraindications • islocated, unstable 2, 3 and D 4-segment fractures of the head of the humerus • algus-impacted 4-segment V fractures of the head of the humerus • seudoarthroses of the head of P the humerus • iaphyseal fractures of the head D of the humerus HUMERAL HEAD PLATE emergency team for broken bones® Locking Humeral Head Plate Fractures of the head of the humerus amount to 5% of all fractures and at least 45% of all humerus fractures. Whereas severe injuries with considerable trauma predominate in younger patients, the head of the humerus can often fracture on slight trauma...

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PHL-5

Position of the patient • eachchair position B • djustable accessory table to A support arm position • mage intensifiers from the head i end locking HUMERAL HEAD PLATE i.t.s. 05

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PHL-6

Surgical technique • eltopectoral access D • aising the calotte fragment r with reposition onto the shaft fragment (fig.1) • emporary fixation of the T reposition using drill wires (fig.2) • et the tubercular fragments S onto the head fragment • osition the humerus plate 5 mm P distal to the proximal end of the tuberculum majus and 10 mm dorsal to the posterior edge of the sulcus intertubercularis • ixation of the humeral head F plate by means of a cortical screw in the sliding hole • ixation of the humeral head F plate by means of a second cortical screw in the shaft • crew down the head of...

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PHL-7

1 2 3 Postoperative • unctionally as early as possible F • f bone quality is bad, shoulder I bandage for max. 4 weeks • assively and actively guided P movement exercises locking HUMERAL HEAD PLATE i.t.s. 07

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PHL-8

HUMERAL HEAD PLATE emergency team for broken bones® Order No. 1 Humeral Head Plate, Small, 3-Hole 21132-3 2 Humeral Head Plate, Small, 4-Hole 21132-4 3 Cancellous Screw, Locking, D=4.2mm, L=38mm, SH 37422-38-N Cancellous Screw, Locking, D=4.2mm, L=40mm, SH 37422-40-N Cancellous Screw, Locking, D=4.2mm, L=42mm, SH 37422-42-N Cancellous Screw, Locking, D=4.2mm, L=44mm, SH 37422-44-N Cancellous Screw, Locking, D=4.2mm, L=46mm, SH 37422-46-N Cancellous Screw, Locking, D=4.2mm, L=48mm, SH 37422-48-N Cancellous Screw, Locking, D=4.2mm, L=50mm, SH 37422-50-N Cancellous Screw, Locking, D=4.2mm, L=55mm,...

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PHL-9

1 2 12 3 11 8 5 10 9 4 7 6 13 locking HUMERAL HEAD PLATE Cortical Screw, Locking, D=3.5mm, L=36mm, SH 37351-36-N 6 Screw Driver, WS 2.5, with Self Holding Sleeve 56252 7 Depth Gauge, Solide Small Fragment Screws 59022 8 Drill Guide, D=2.0/2.7mm 62202 9 Spiral Drill, D=2.5mm, L=180mm, AO Connector 61253-180 10 Spiral Drill, D=2.7mm, L=100mm, AO Connector 61273-100 11 Guide Wire, Steel, D=2.0mm, L=228mm, TR 35204-228 12 Cortical Counter Sink, with Stop support 63404 13 Sterilization Tray, Humeral Head Plate 50186 i.t.s. 09

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PHL-10

LOCKING Locking works because of: • Screw material (TiAlV) is slightly harder than plate material (Titanium Grade 2) • Screw head forms thread into the plate (no cutting) Benefits: • • • • • ± 15° and Locking No pre threading No cold welding No debris Re-setting of screw (up to 3 times) 30° ® DOTIZE Chemical process - anodization in a strong alkaline solution * Type III anodization Dotize Type II anodization Layer thickness 60-200nm Layer thickness 2000-10 000nm + Different colors + Film become an interstitial part of the titanium - Implant surface remains sensitive to: Chipping Peeling Discoloration...

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PHL-12

Sterilization Guidelines The following remarks should serve as a guideline in the sterilization of medical products. IMPORTANT INDICATIONS FOR DOCTORS AND OPERATING THEATRE PERSONNEL This instruction leaflet refers to all supplied nonsterile implants and all reusable instruments from I.T.S. GmbH. Detailed information for the identification of the product (such as system classification, cat. no.) can be found in the product identification code and/ or on the package label. Make sure that you are familiar with the possibilities of application, combinability and correct handling of the product....

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PHL-13

Sterilization Guidelines Disinfection Equipment: Commercially available disinfectants authorized for use with medical products e.g.. MEDICLEAN FORTE) can be used (but only according to the instructions of the disinfectant producer). In the case of automatic cleaning, a final rinse cycle at 90 °C for 5 minutes can be finally carried out to provide thermal disinfection. Drying Drying as part of the cleaning/ disinfection cycle should not exceed 110 °C. Checking, Maintenance and Inspection • Each instrument or implant is to be inspected carefully to make sure that all visible dirt has been removed....

 Open the catalog to page 13

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.